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FDA Approves Risperdal for Treatment of Symptoms Associated with Autism

September 01, 2007

The U.S. Food and Drug Administration (FDA) has given Johnson & Johnson approval to market Risperdal (risperidone) for the treatment of irritability associated with

autism, including symptoms of aggression, deliberate self-injury, temper tantrums and rapid mood swings in children and adolescents ages 5 to 16. This is the first time the FDA has approved any medication for use in children and adolescents with autism. The drug is marketed by Janssen, L.P, a subsidiary of Johnson & Johnson.

Physicians have been prescribing risperidone “off-label” to treat certain behavioral symptoms associated with autism for more than 10 years. With FDA approval, more physicians will have clearer instructions on when and how to prescribe risperidone for their patients with autism. Although no one treatment is appropriate for all children on the autism spectrum, this is good news for families that have seen successful treatment with risperidone but were not previously able to secure insurance coverage for the medication. While risperidone does not treat the core symptoms of autism--communication deficits, impaired social interactions and stereotyped behaviors or interests--it has been shown to be beneficial in treating the associated behavioral disturbances that can interfere with school and family life.

For more information about Risperdal, including the press release from Johnson & Johnson, visit